EP3063327A1 - Kit and method for cleaning and disinfecting medical instruments and appliances - Google Patents

Kit and method for cleaning and disinfecting medical instruments and appliances

Info

Publication number
EP3063327A1
EP3063327A1 EP14727524.2A EP14727524A EP3063327A1 EP 3063327 A1 EP3063327 A1 EP 3063327A1 EP 14727524 A EP14727524 A EP 14727524A EP 3063327 A1 EP3063327 A1 EP 3063327A1
Authority
EP
European Patent Office
Prior art keywords
instruments
cleaning
kit
kit according
medical
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP14727524.2A
Other languages
German (de)
French (fr)
Other versions
EP3063327B1 (en
Inventor
Iris Strodtholz
Petra Reessing
Jürgen Staffeldt
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Chemische Fabrik Dr Weigert GmbH and Co
Original Assignee
Chemische Fabrik Dr Weigert GmbH and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
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Priority to SI201431089T priority Critical patent/SI3063327T1/en
Priority to PL14727524T priority patent/PL3063327T3/en
Priority to EP14727524.2A priority patent/EP3063327B1/en
Priority to RS20190181A priority patent/RS58348B1/en
Application filed by Chemische Fabrik Dr Weigert GmbH and Co filed Critical Chemische Fabrik Dr Weigert GmbH and Co
Publication of EP3063327A1 publication Critical patent/EP3063327A1/en
Publication of EP3063327B1 publication Critical patent/EP3063327B1/en
Application granted granted Critical
Priority to CY20191100210T priority patent/CY1121271T1/en
Priority to HRP20190316TT priority patent/HRP20190316T1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • D—TEXTILES; PAPER
    • D06—TREATMENT OF TEXTILES OR THE LIKE; LAUNDERING; FLEXIBLE MATERIALS NOT OTHERWISE PROVIDED FOR
    • D06F—LAUNDERING, DRYING, IRONING, PRESSING OR FOLDING TEXTILE ARTICLES
    • D06F39/00—Details of washing machines not specific to a single type of machines covered by groups D06F9/00 - D06F27/00 
    • D06F39/02—Devices for adding soap or other washing agents
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/38—Products with no well-defined composition, e.g. natural products
    • C11D3/386—Preparations containing enzymes, e.g. protease or amylase
    • C11D3/38618—Protease or amylase in liquid compositions only
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
    • A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
    • B08B3/04—Cleaning involving contact with liquid
    • B08B3/08—Cleaning involving contact with liquid the liquid having chemical or dissolving effect
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B08—CLEANING
    • B08B—CLEANING IN GENERAL; PREVENTION OF FOULING IN GENERAL
    • B08B3/00—Cleaning by methods involving the use or presence of liquid or steam
    • B08B3/04—Cleaning involving contact with liquid
    • B08B3/10—Cleaning involving contact with liquid with additional treatment of the liquid or of the object being cleaned, e.g. by heat, by electricity or by vibration
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/26—Organic compounds containing nitrogen
    • C11D3/30—Amines; Substituted amines ; Quaternized amines
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/26—Organic compounds containing nitrogen
    • C11D3/33—Amino carboxylic acids
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D3/00—Other compounding ingredients of detergent compositions covered in group C11D1/00
    • C11D3/16—Organic compounds
    • C11D3/38—Products with no well-defined composition, e.g. natural products
    • C11D3/386—Preparations containing enzymes, e.g. protease or amylase
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22—Organic compounds
    • C11D7/32—Organic compounds containing nitrogen
    • C11D7/3218—Alkanolamines or alkanolimines
    • C—CHEMISTRY; METALLURGY
    • C11—ANIMAL OR VEGETABLE OILS, FATS, FATTY SUBSTANCES OR WAXES; FATTY ACIDS THEREFROM; DETERGENTS; CANDLES
    • C11D—DETERGENT COMPOSITIONS; USE OF SINGLE SUBSTANCES AS DETERGENTS; SOAP OR SOAP-MAKING; RESIN SOAPS; RECOVERY OF GLYCEROL
    • C11D7/00—Compositions of detergents based essentially on non-surface-active compounds
    • C11D7/22—Organic compounds
    • C11D7/32—Organic compounds containing nitrogen
    • C11D7/3245—Aminoacids
    • C11D2111/20—

Definitions

  • the invention relates to a kit and a method for the automated cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus.
  • Surgical instruments and other medical equipment are conventionally mechanically cleaned in the hospital using alka ⁇ Lischer detergent and ⁇ closing disinfected chemically or thermally.
  • alka ⁇ Lischer detergent and ⁇ closing disinfected chemically or thermally Such strong alkaline agents can be aggressive to sensitive surfaces.
  • Blood-contaminated surgical instruments are often placed directly after their use, for example, in a disinfectant solution and remain there first, until they are cleared for cleaning in the dishwasher.
  • the blood is coagulated by the Desin ⁇ Stammionsstoff and the egg white contained in the blood components by the disinfectant active ingredient of denaturation ⁇ riert.
  • Particularly persistent blood residues are often only be removed by alkaline active-chlorine-containing cleanser ⁇ tel.
  • the oxidizing Aktivchlorkomponente be ⁇ acts the decomposition of the denatured protein components.
  • Other constituents of disinfectants such as, for example, iodine can form residues that are difficult to remove.
  • alkaline-active chlorine-containing cleaners have the disadvantages that they contain hazardous substances subject to labeling, that special care must be taken when handling them. measures to protect the operating personnel are required and that they constitute an undesirable Plantbe ⁇ loading in the waste water.
  • US-A-4,243,546, EP-A-0 481 663 and EP-A-0 730 024 disclose enzyme-containing detergents which in particular can enzymatically degrade blood proteins.
  • EP-A-1 021 519 discloses an enzyme-free detergent concentrate for cleaning surgical instruments.
  • EP-A-1 327 674 discloses a detergent concentrate for medical instruments containing an alkanolamine, enzymes and aminopolycarboxylic acids as complexing agents.
  • the invention has for its object to provide a way for effective cleaning of medical and surgical instruments and instruments, which is in practice a ⁇ easy to handle and in which only small volumes of detergents are vorzuhalten.
  • the invention achieves this object by a kit for the mechanical cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus, characterized in that it contains: a. a first component containing at least 15 wt .-% alkanolamine and at least 10 wt .-% ⁇ complexing ner; b. a second component containing at least one enzyme.
  • Detergents and / or disinfectants for medical and / or surgical elements and apparatuses are agents which at least reduce dirt and germ contamination during the processing of such instruments.
  • a machine cleaning takes place in a suitable dishwasher, preferably in a usual cleaning and disinfection device for medical or surgical instruments (RDG).
  • RDG medical or surgical instruments
  • the kit of the invention contains two Components ⁇ least ten.
  • the first component also called alkali component
  • the second component also referred to Enzymkompo ⁇ component
  • the amount of these proteolytic enzymes is preferably between 0.05 and 1 Anson units per g component.
  • the components of the kit in storage containers with a content of, for example, 5 to 20 l in hospital operation.
  • Such containers or canisters are easy to transport and can be stored in the operation in the immediate vicinity of the cleaning and disinfection device used and are ⁇ closed.
  • It is according to the invention did not lend necessary for an adequate operating time large volumes, for example in the form of barrels with 200 1 content to be ⁇ vorraten that require a complex system of supply lines usually because drums with such content usually not directly on cleaning - And disinfection device can be stored, but are arranged in a separate storage room and must therefore be connected via long lines to the point of consumption.
  • Separation of the components of the cleaning or disinfecting agent on two components allows the provision of so-called high concentrates, in which not or only can be (for example, alkaline alkanolamines one hand, and enzyme on the other hand) mounted difficult mutually compatible ingredients in higher concentrations stable and available ge ⁇ hold than a detergent with le- diglich a component.
  • high concentrates in which not or only can be (for example, alkaline alkanolamines one hand, and enzyme on the other hand) mounted difficult mutually compatible ingredients in higher concentrations stable and available ge ⁇ hold than a detergent with le- diglich a component.
  • the alkanolamine content of the first component is at ei ⁇ ner preferred embodiment of the invention, 15-30 wt .-%, more preferably 15-25 wt .-%.
  • the alkanolamine may preferably have the following structure:
  • R] _ is a hydroxyalkyl group having 1 to 6 carbon atoms ⁇ represents and wherein R2 and R3 independently represent ge ⁇ called hydroxyalkyl group or hydrogen. More preferably, the alkanolamine is selected from the group consisting of mono-, di- and / or triethanolamine.
  • the first component may preferably contain 10-30% by weight, more preferably 15-25% by weight of complexing agent.
  • the complexing agents serve to soften the water and, by complexing alkaline earth ions, can improve the cleaning action against typical OP impurities.
  • the complexing agents may be homopolymers, copolymers or terpolymers based on acrylic acid or their alkali metal salts, furthermore phosphonic acids or their alkali metal salts, such as, for example, 1-hydroxyethane-1,1-diphosphonic acid, aminotrismethylphosphonic acid Ethylenediaminotetrakismethylenephosphonic acid, phosphonobutanetricarboxylic acid; Tartaric acid, citric acid and gluconic acid; also nitrilotriacetic acid or ethylenediaminotetraacetic acid or salts thereof.
  • the corrosive effect of chelating agents on anodized aluminum surfaces and the like can be reduced or completely avoided by the addition of at least one mono- and / or diester of phosphoric acid with alipha ⁇ tables Alkolholen the chain length of Ci to C22 and / or aliphatic diols and / or aliphatic polyols chain length C2 to C22.
  • Particularly preferred is a diester of phosphoric acid with butanol on the one hand and ethylene glycol on the other hand.
  • This ester is commercially available under the Be ⁇ drawing Hordaphos® MDGB. According to the invention, this gives a good cleaning effect even when using hard water and still a gentle action on anodized aluminum surfaces.
  • the second component may contain at least one proteolytic enzyme.
  • Suitable proteolytic enzymes are available, for example, from the company Novozymes under the name Esperase® 8.0 L, Subtilisin® or Liquanase® Ultra 2.0 L.
  • the second component can contain before ⁇ preferably nonionic surfactants, in the present invention surfactants.
  • ⁇ ionic and cationic surfactants can inventively be lethoxylaten ⁇ selected from the group consisting of fatty alcohols, fatty alcohol propoxylates, EO-PO block copolymers, alkylglucosides, alkylpolyglucosides, Oc- tylphenol ethoxylates and nonylphenol ethoxylates.
  • Known to those skilled ethoxylated and / or propoxylated fatty alcohol ⁇ alcohols are particularly preferred.
  • Such nonionic surfactants are available, for example, from the companies Cognis or Julius Hoesch.
  • the second component may be added usual preser ⁇ tives, eg. P-hydroxybenzoic acid or its Methylester, 5-bromo-5-nitro-l, 3-dioxane, salicylic, 2-naphthyl-mN-Dimethylthiocarbanilat, 5-chloro -5-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, cetyltrimethylammonium chloride (CTAC) and mixtures of these compounds.
  • Another preservative is p-hydroxybenzoic acid or its methyl ester. With the help of these preservatives microbial and fungal infestation of the components can be avoided.
  • formulation aids can (ozomitt ⁇ ler) are added such as. Sodium cumene sulfonate, NAT riumtoluolsulfonat, sodium xylene sulfonate, urea, glyco- le, in particular polypropylene glycols and Polyethylenglyko- le, methylacetamide and fatty alcohols such as cetyl alcohol or.
  • wetting agents for example.
  • emulsifiers for example.
  • N-acylglutamate as wetting agent is advantageous.
  • Another object of the invention is the use of a kit according to the invention for the mechanical cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus. Such a machine cleaning takes place without human intervention during an automatic program sequence, in particular ⁇ special in a conventional instrument dishwasher (RDG).
  • RDG instrument dishwasher
  • the kit of the invention ⁇ can be used in the combination of cleaning and disinfection in a single step and in Programmab ⁇ runs probably the case in which a cleaning step, a separate Disinfection step follows.
  • the kit according to the invention is usable in both of these steps.
  • the invention likewise relates to a method for cleaning medical and / or surgical instruments and / or apparatus, characterized by the following steps: a) application of a 0.05 to 0.5% aqueous solution of the components of a kit according to the invention, b) exposure the solution at a temperature from room temperature to the boiling point of the solution, c) rinsing.
  • the application of the aqueous solution of the cleaning agent concentrate is preferably carried out by spraying, but may, for example, also take place by immersion or pouring.
  • the percentages are by weight, unless otherwise specified in the specific case.
  • the exposure may after application of the cleaning solution comprise an action at rest, ie without continuous application or spraying or mechanical circulation or moving the cleaning solution.
  • a RESISTING ⁇ ended or interrupted circulation of the cleaning solution used in the RDG is preferably continued ⁇ continuously sprayed onto the equipment and instruments, or flushed away.
  • the components of the kit can be metered directly into the aqueous solution used as cleaning liquor.
  • the exposure in step b) is preferably carried out at room temperature to 55 ° C, preferably at 35 to 50 ° C, wei ⁇ ter preferably at 40 to 50 ° C.
  • the aqueous solution of the components of the kit preferably has a pH of 9 to 11, more preferably 10 to 11. If pH values of a dilute solution of the cleaning agent concentration are measured within the scope of the present application, demineralized water (demineralized water) is used as the solvent. If the concentrate is set with reasonable übli ⁇ chem tap water to a use solution, may arise depending on the nature of this What ⁇ sers slightly different pH values.
  • the pH of the concentrates / components is adjusted to the desired range by adding acids and / or suitable buffer systems.
  • the addition of at least one organic acid is selected from the group consisting of mono-, di- or tricarboxylic acids having 2 to 6 carbon atoms.
  • these acids preference is given to citric acid, tartaric acid, malic acid, acid, glycolic acid, glyoxylic acid, succinic acid, adipic acid and glutaric ⁇ .
  • Citric acid is especially before ⁇ Trains t.
  • the acids are preferably added to the concentrate in small amounts. Some of these mentioned organic acids such as citric acid are equal ⁇ time complexing agents according to the invention.
  • the exposure time in step b) is preferably 1 minute to 30 minutes, more preferably 3 to 20 minutes, further preferably 5 to 15 minutes.
  • This program control is designed to demand-based dosing of the two components depending on the performed cleaning and disinfection process.
  • the Pro ⁇ programs may preferably have different concentrations of the two components and also adjust the ratio to each other of the components used in different ways. For example, in the preparation of conventional surgical instruments, a higher concentration of the alkali component can be chosen as in the treatment of sensitive instruments for minimally invasive Chi ⁇ rurgie (MIS instruments) or endoscopes.
  • the volume ratio of the two components to each other ⁇ can according to the invention preferably is between 1:10 and 10: 1, more pre- preferably 1: 5 and 5: 1, more preferably 1: 2 and 2:. 1 lie ⁇ gene in a standard cleaning or disinfection, it may for example be 1: 1.
  • the concentration of both components together in the cleaning solution in the inventive method is between 0.05 and 0.5 wt. ⁇ 6, preferably 0.08 and 0.3 wt .-% before.
  • Preferred ranges for each of the two components are 0.02 to 0.3 wt%, more preferably 0.04 and 0.15 wt%.
  • a device for recognition of the type which is intended to cleaning and disinfecting medical instruments and equipment and to the off ⁇ choice of a suitable cleaning and disinfecting method and -Programms function of this type.
  • This approach may be particularly useful if each batch of identical or similar instruments are cleaned, for example, conventional chirur ⁇ gical instruments, MIC instruments or the like.
  • the detection of the type of instruments can be mechanical or optical, for example by scanning the height in the instrument basket, optical detection of the instruments or the like. It is preferred if either on the instruments themselves or on the baskets, by means of which they are brought into the washer-disinfector, Coding devices are present, which interact with corresponding reading devices of the washer-disinfector. For example, these may be RFID tags and RFID readers.
  • Instruments and apparatus selected from the group consisting of conventional surgical instruments, instruments for minimally invasive surgery, endoscopes and their parts, instruments for neurosurgery,
  • Example 1 An alkali component according to the invention is prepared on the basis of the data given in the following table. The amounts of the starting materials to be used are given in parts by weight.
  • An enzyme component according to the invention is prepared as follows:
  • heparinized mutton blood (Acila) are mixed with 1 ml of deionised water and re-coagulated with 150 ⁇ l protamine sulfate (1,000 IU / ml to inactivate 1,000 IU heparin each).
  • the thus prepared blood was applied to the metal flakes and dried overnight at room temperature.
  • the cleaning solutions were heated to 55 ° C and stirred with egg ⁇ nem magnetic stirrer at 3.5.
  • the metal flakes were immersed in the solutions for 5 minutes and then rinsed with deionised water. Subsequently, the Metallplätt ⁇ surfaces were dried overnight, evaluated visually, then stained with 0.1% Amidoschwarzates for testing for residual amounts of proteins and re-evaluated visually.
  • the achieved cleaning performance according to the example of the invention was identical to the cleaning performance of the same example.
  • This example thus proves that an equally good cleaning performance can be achieved with substantially lower concentrations of cleaning agents than in the prior art used as comparative example and thus also with only a fraction of the volumes of cleaning components used. This is surprising and not derivable from the prior art.

Abstract

The invention relates to a kit for mechanically cleaning and/or disinfecting medical and/or surgical instruments and/or devices, said kit containing a first component, which contains at least 15 wt.% alkanolamine and at least 10 wt.% complexing agent, and a second component containing at least one enzyme. Said kit enables surgical and medical instruments to be cleaned and disinfected in an effective manner with very low quantities.

Description

Kit und Verfahren zur Reinigung und Desinfektion von medizinischen Instrumenten und Apparaten Die Erfindung betrifft einen Kit und ein Verfahren zur maschinellen Reinigung und/oder Desinfektion medizinischer und/oder chirurgischer Instrumente und/oder Apparate.  The invention relates to a kit and a method for the automated cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus.
Chirurgische Instrumente sowie andere medizinische Geräte werden im Krankenhaus üblicherweise unter Verwendung alka¬ lischer Reinigungsmittel maschinell gereinigt und an¬ schließend chemisch oder thermisch desinfiziert. Solche stark alkalischen Mittel können aggressiv gegenüber empfindlichen Oberflächen wirken. Mit Blut verunreinigte chi- rurgische Instrumente werden häufig unmittelbar nach ihrer Benutzung bspw. in eine Desinfektionslösung abgelegt und verbleiben darin zunächst, bis sie zum Reinigen in die Spülmaschine geräumt werden. Das Blut wird durch die Desin¬ fektionsmittel koaguliert und die im Blut enthaltenen Ei- weißbestandteile durch den Desinfektionswirkstoff denatu¬ riert. Solche besonders hartnäckigen Blutrückstände sind häufig nur durch alkalisch-aktivchlorhaltige Reinigungsmit¬ tel zu entfernen. Die oxidierende Aktivchlorkomponente be¬ wirkt die Zersetzung der denaturierten Eiweißbestandteile. Auch andere Bestandteile von Desinfektionsmitteln wie bspw. Jod können schwer zu entfernende Rückstände bilden. Surgical instruments and other medical equipment are conventionally mechanically cleaned in the hospital using alka ¬ Lischer detergent and ¬ closing disinfected chemically or thermally. Such strong alkaline agents can be aggressive to sensitive surfaces. Blood-contaminated surgical instruments are often placed directly after their use, for example, in a disinfectant solution and remain there first, until they are cleared for cleaning in the dishwasher. The blood is coagulated by the Desin ¬ fektionsmittel and the egg white contained in the blood components by the disinfectant active ingredient of denaturation ¬ riert. Particularly persistent blood residues are often only be removed by alkaline active-chlorine-containing cleanser ¬ tel. The oxidizing Aktivchlorkomponente be ¬ acts the decomposition of the denatured protein components. Other constituents of disinfectants such as, for example, iodine can form residues that are difficult to remove.
Die alkalisch-aktivchlorhaltigen Reiniger weisen die Nachteile auf, dass sie kennzeichnungspflichtige Gefahrenstoffe enthalten, dass bei ihrer Handhabung besondere Vorsichts- maßnahmen zum Schutz des Bedienungspersonals erforderlich sind und dass sie im Abwasser eine unerwünschte Umweltbe¬ lastung darstellen. Aus US-A-4 243 546, EP-A-0 481 663 und EP-A-0 730 024 sind enzymhaltige Reinigungsmittel bekannt, die insbesondere Blutproteine enzymatisch abbauen können. The alkaline-active chlorine-containing cleaners have the disadvantages that they contain hazardous substances subject to labeling, that special care must be taken when handling them. measures to protect the operating personnel are required and that they constitute an undesirable Umweltbe ¬ loading in the waste water. US-A-4,243,546, EP-A-0 481 663 and EP-A-0 730 024 disclose enzyme-containing detergents which in particular can enzymatically degrade blood proteins.
EP-A-1 021 519 offenbart ein enzymfreies Reinigungsmittel- konzentrat zur Reinigung chirurgischer Instrumente. AlsEP-A-1 021 519 discloses an enzyme-free detergent concentrate for cleaning surgical instruments. When
Nachteil der enzymatischen Reiniger wird dort genannt, dass die Enzymaktivität bei längerer Lagerung nachlassen kann. Disadvantage of the enzymatic cleaner is mentioned there, that the enzyme activity can diminish after prolonged storage.
EP-A-1 327 674 offenbart ein Reinigungsmittelkonzentrat für medizinische Instrumente, das ein Alkanolamin, Enzyme und Aminopolycarbonsäuren als Komplexbildner enthält. EP-A-1 327 674 discloses a detergent concentrate for medical instruments containing an alkanolamine, enzymes and aminopolycarboxylic acids as complexing agents.
Der Erfindung liegt die Aufgabe zugrunde, eine Möglichkeit zur wirksamen Reinigung medizinischer und chirurgischer In- strumente und Apparate zu schaffen, die in der Praxis ein¬ fach handhabbar ist und bei der lediglich geringe Volumina von Reinigungsmitteln vorzuhalten sind. The invention has for its object to provide a way for effective cleaning of medical and surgical instruments and instruments, which is in practice a ¬ easy to handle and in which only small volumes of detergents are vorzuhalten.
Die Erfindung löst diese Aufgabe durch einen Kit zur ma- schinellen Reinigung und/oder Desinfektion medizinischer und/oder chirurgischer Instrumente und/oder Apparate, dadurch gekennzeichnet, dass er enthält: a. eine erste Komponente, die wenigstens 15 Gew.-% Alkanolamin und wenigstens 10 Gew.-% Komplexbild¬ ner enthält; b. eine zweite Komponente, die wenigstens ein Enzym enthält . The invention achieves this object by a kit for the mechanical cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus, characterized in that it contains: a. a first component containing at least 15 wt .-% alkanolamine and at least 10 wt .-% ¬ complexing ner; b. a second component containing at least one enzyme.
Zunächst seien einige im Rahmen der Erfindung verwendete Begriffe erläutert. First, some terms used in the invention are explained.
Reinigungs- und/oder Desinfektionsmittel für medizinische und/oder chirurgische Elemente und Apparate sind solche Mittel, die im Zuge der Aufarbeitung solcher Instrumente die Schmutz- und Keimbelastung zumindest verringern. Detergents and / or disinfectants for medical and / or surgical elements and apparatuses are agents which at least reduce dirt and germ contamination during the processing of such instruments.
Eine maschinelle Reinigung erfolgt in einer geeigneten Spülmaschine, vorzugsweise in einem üblichen Reinigung- und Desinfektionsgerät für medizinische bzw. chirurgische In- strumente (RDG) . Dieser Begriff ist definiert in ISO 15883- 1. A machine cleaning takes place in a suitable dishwasher, preferably in a usual cleaning and disinfection device for medical or surgical instruments (RDG). This term is defined in ISO 15883-1.
Der erfindungsgemäße Kit enthält wenigstens zwei Komponen¬ ten. Die erste Komponente (auch Alkalikomponente genannt) enthält verhältnismäßig hohe Konzentrationen Alkanolamin und Komplexbildner. Die zweite Komponente (auch Enzymkompo¬ nente genannt) enthält wenigstens ein Enzym, vorzugsweise ein proteolytisches Enzym. Die Menge dieser proteolytischen Enzyme liegt bevorzugt zwischen 0,05 und 1 Anson-Einheiten pro g Komponente. The kit of the invention contains two Components ¬ least ten. The first component (also called alkali component) contains relatively high concentrations of alkanolamine and complexing agents. The second component (also referred to Enzymkompo ¬ component) contains at least one enzyme, preferably a proteolytic enzyme. The amount of these proteolytic enzymes is preferably between 0.05 and 1 Anson units per g component.
Überraschenderweise hat sich gezeigt, dass sich durch Auf¬ teilen dieser grundsätzlich bekannten Bestandteile eines Reinigungsmittels auf zwei Komponenten in der beanspruchten Art und Weise eine sehr wirksame Reinigung bzw. Desinfekti¬ on medizinischer Instrumente mit sehr geringen Wirkstoffmengen und vor allen Dingen auch mit sehr geringen eingesetzten Volumina der beiden Komponenten erreichen lässt. Wie unten in den Beispielen noch erläutert werden wird, kann beispielsweise eine im Volumenverhältnis eins zu eins hergestellte Mischung von zwei erfindungsgemäßen Komponenten des Kits als 0,2 %ige wässrige Lösung angesetzt werden und hat eine gute Wirksamkeit gegenüber den üblichen Misch¬ verschmutzungen chirurgischer Instrumente. Surprisingly, it has been found that this in principle known components of a cleaning agent share two components in the claimed way, a very effective cleaning or Desinfekti ¬ on medical instruments with very small amounts of active agent by on ¬ and above all used also with very low Volume of the two components can be achieved. As will be explained below in the examples, such as one made in the ratio of one to one mixture of two inventive components of the kit can be used as 0.2% aqueous solution are recognized and has good activity against the conventional mixing ¬ soiling of surgical instruments.
Erfindungsgemäß ist es somit möglich, im Krankenhausbetrieb die Komponenten des Kits in Vorratsbehältern mit einem In- halt von beispielsweise 5 bis 20 1 zu bevorraten. Solche Behälter oder Kanister lassen sich leicht transportieren und können im Betrieb in unmittelbarer Nähe des verwendeten Reinigungs- und Desinfektionsgerätes gelagert und ange¬ schlossen werden. Es ist erfindungsgemäß nicht erforder- lieh, für eine hinreichende Betriebsdauer große Volumina beispielsweise in Form von Fässern mit 200 1 Inhalt zu be¬ vorraten, die in der Regel ein aufwändiges System von Versorgungsleitungen benötigen, da Fässer mit einem solchen Inhalt üblicherweise nicht unmittelbar am Reinigungs- und Desinfektionsgerät gelagert werden können, sondern in einem separaten Lagerraum angeordnet werden und dementsprechend über lange Leitungen mit der Verbrauchsstelle verbunden werden müssen. Überraschenderweise hat sich gezeigt, dass der Einsatz ei¬ nes Alkanolamins als Bestandteil der alkalischen Komponente in der beanspruchten Mindestkonzentration zu einer besonders guten Wirksamkeit bei sehr geringen Dosiermengen bzw. Konzentrationen der Komponenten des Kits in die wässrige Reinigungslösung führen. Die erfindungsgemäß vorgeseheneAccording to the invention, it is thus possible to store the components of the kit in storage containers with a content of, for example, 5 to 20 l in hospital operation. Such containers or canisters are easy to transport and can be stored in the operation in the immediate vicinity of the cleaning and disinfection device used and are ¬ closed. It is according to the invention did not lend necessary for an adequate operating time large volumes, for example in the form of barrels with 200 1 content to be ¬ vorraten that require a complex system of supply lines usually because drums with such content usually not directly on cleaning - And disinfection device can be stored, but are arranged in a separate storage room and must therefore be connected via long lines to the point of consumption. Surprisingly, it has been found that the use of egg ¬ nes alkanolamine lead as a component of the alkaline component in the claimed minimum concentration to a particularly good efficacy at very low dosage levels or concentrations of components of the kit in the aqueous cleaning solution. The inventively provided
Auftrennung der Bestandteile des Reinigungs- bzw. Desinfektionsmittels auf zwei Komponenten erlaubt das Bereitstellen so genannter Hochkonzentrate, bei denen nicht oder nur schwer miteinander kompatible Inhaltsstoffe (beispielsweise alkalische Alkanolamine einerseits und Enzym andererseits) in höheren Konzentrationen stabil gelagert und vorrätig ge¬ halten werden können als bei einem Reinigungsmittel mit le- diglich einer Komponente. Separation of the components of the cleaning or disinfecting agent on two components allows the provision of so-called high concentrates, in which not or only can be (for example, alkaline alkanolamines one hand, and enzyme on the other hand) mounted difficult mutually compatible ingredients in higher concentrations stable and available ge ¬ hold than a detergent with le- diglich a component.
Der Alkanolamingehalt der ersten Komponente beträgt bei ei¬ ner bevorzugten Ausführungsform der Erfindung 15-30 Gew.-%, weiter vorzugweise 15-25 Gew.-%. Das Alkanolamin kann be- vorzugt die folgende Struktur aufweisen: The alkanolamine content of the first component is at ei ¬ ner preferred embodiment of the invention, 15-30 wt .-%, more preferably 15-25 wt .-%. The alkanolamine may preferably have the following structure:
R2 R2
I  I
R! - N - R3 wobei R]_ eine Hydroxyalkylgruppe mit 1 bis 6 C-Atomen dar¬ stellt und wobei R2 und R3 unabhängig voneinander die ge¬ nannte Hydroxyalkylgruppe oder Wasserstoff darstellen. Weiter bevorzugt ist das Alkanolamin ausgewählt aus der Gruppe bestehend aus Mono-, Di- und/oder Triethanolamin . R! - N - R 3 wherein R] _ is a hydroxyalkyl group having 1 to 6 carbon atoms ¬ represents and wherein R2 and R3 independently represent ge ¬ called hydroxyalkyl group or hydrogen. More preferably, the alkanolamine is selected from the group consisting of mono-, di- and / or triethanolamine.
Die erste Komponente kann bevorzugt 10-30 Gew.-%, weiter vorzugsweise 15-25 Gew.-% Komplexbildner enthalten. Die Komplexbildner dienen der Wasserenthärtung und können durch Komplexieren von Erdalkalionen die Reinigungswirkung gegenüber OP-typischen Verunreinigungen verbessern. Bei den Komplexbildnern kann es sich um Homo-, Co- oder Terpolymere auf der Basis von Acrylsäure oder deren Alkalisalzen han- dein, ferner um Phosphonsäuren bzw. deren Alkalisalze, wie bspw. 1-Hydroxyethan-l , 1-diphosphonsäure, Aminotrismethyl- enphosphonsäure, Ethylendiaminotetrakismethylenphosphonsäu- re, Phosphonobutantricarbonsäure ; Weinsäure, Citronensäure und Glukonsäure ; ferner Nitrilotriessigsäure oder Ethylen- diaminotetraessigsäure bzw. deren Salze. Bevorzugt ist die Verwendung von Chelatbildnern, insbesondere Ami- no (poly) carbonsäuren sowie deren Salzen, beispielsweise das Trinatriumsalz der Methylglycindiessigsäure (MGDA) . The first component may preferably contain 10-30% by weight, more preferably 15-25% by weight of complexing agent. The complexing agents serve to soften the water and, by complexing alkaline earth ions, can improve the cleaning action against typical OP impurities. The complexing agents may be homopolymers, copolymers or terpolymers based on acrylic acid or their alkali metal salts, furthermore phosphonic acids or their alkali metal salts, such as, for example, 1-hydroxyethane-1,1-diphosphonic acid, aminotrismethylphosphonic acid Ethylenediaminotetrakismethylenephosphonic acid, phosphonobutanetricarboxylic acid; Tartaric acid, citric acid and gluconic acid; also nitrilotriacetic acid or ethylenediaminotetraacetic acid or salts thereof. Preference is given to the use of chelating agents, in particular amino (poly) carboxylic acids and their salts, for example the trisodium salt of methylglycinediacetic acid (MGDA).
Die korrosive Wirkung von Komplexbildnern auf eloxierte Aluminiumoberflächen und dergleichen kann vermindert bzw. vollständig vermieden werden durch den Zusatz wenigstens eines Mono- und/oder Diesters der Phosphorsäure mit alipha¬ tischen Alkolholen der Kettenlänge Ci bis C22 und/oder aliphatischen Diolen und/oder aliphatischen Polyolen der Kettenlänge C2 bis C22 · Besonders bevorzugt ist ein Diester der Phosphorsäure mit Butanol einerseits und Ethylenglykol andererseits. Dieser Ester ist kommerziell unter der Be¬ zeichnung Hordaphos® MDGB erhältlich. Erfindungsgemäß erhält man so eine gute Reinigungswirkung auch bei Verwendung harten Wassers und trotzdem eine schonende Einwirkung auf eloxierte Aluminiumflächen. The corrosive effect of chelating agents on anodized aluminum surfaces and the like can be reduced or completely avoided by the addition of at least one mono- and / or diester of phosphoric acid with alipha ¬ tables Alkolholen the chain length of Ci to C22 and / or aliphatic diols and / or aliphatic polyols chain length C2 to C22. Particularly preferred is a diester of phosphoric acid with butanol on the one hand and ethylene glycol on the other hand. This ester is commercially available under the Be ¬ drawing Hordaphos® MDGB. According to the invention, this gives a good cleaning effect even when using hard water and still a gentle action on anodized aluminum surfaces.
Die zweite Komponente kann wenigstens ein proteolytisches Enzym enthalten. Geeignete proteolytische Enzyme sind bspw. von der Fa. Novozymes unter der Bezeichnung Esperase® 8.0 L, Subtilisin® oder Liquanase® Ultra 2.0 L erhältlich. The second component may contain at least one proteolytic enzyme. Suitable proteolytic enzymes are available, for example, from the company Novozymes under the name Esperase® 8.0 L, Subtilisin® or Liquanase® Ultra 2.0 L.
Die zweite Komponente kann erfindungsgemäß Tenside, vor¬ zugsweise nichtionische Tenside, enthalten. Der Zusatz an¬ ionischer und kationischer Tenside ist ebenfalls möglich. Die nichtionischen Tenside können erfindungsgemäß ausge¬ wählt sein aus der Gruppe bestehend aus Fettalkoho- lethoxylaten, Fettalkoholpropoxylaten, EO-PO- Blockcopolymeren, Alkylglucosiden, Alkylpolyglucosiden, Ok- tylphenolethoxylaten und Nonylphenolethoxylaten . Dem Fachmann geläufige ethoxylierte und/oder propoxylierte Fettal¬ kohole sind besonders bevorzugt. Solche nichtionischen Ten- side sind beispielsweise von den Firmen Cognis oder Julius Hoesch erhältlich. The second component can contain before ¬ preferably nonionic surfactants, in the present invention surfactants. The addition of ¬ ionic and cationic surfactants is also possible. The nonionic surfactants can inventively be lethoxylaten ¬ selected from the group consisting of fatty alcohols, fatty alcohol propoxylates, EO-PO block copolymers, alkylglucosides, alkylpolyglucosides, Oc- tylphenol ethoxylates and nonylphenol ethoxylates. Known to those skilled ethoxylated and / or propoxylated fatty alcohol ¬ alcohols are particularly preferred. Such nonionic surfactants are available, for example, from the companies Cognis or Julius Hoesch.
Insbesondere der zweiten Komponente können übliche Konser¬ vierungsmittel zugesetzt werden, bspw. p-Hydroxybenzoesäure oder deren Methylester, 5-Brom-5-Nitro-l , 3-dioxan, Salicyl- säure, 2-Naphtyl-m-N-Dimethylthiocarbanilat , 5-Chlor-5- methyl-4-isothiazolin-3-on, 2-Methyl-4-isothiazolin-3-on, Cetyltrimethylammoniumchlorid (CTAC) sowie Gemische dieser Verbindungen. Ein weiteres Konservierungsmittel ist p- Hydroxybenzoesäure bzw. deren Methylester. Mit Hilfe dieser Konservierungsmittel läßt sich Mikroben- und Pilzbefall der Komponenten vermeiden. In particular, the second component may be added usual preser ¬ tives, eg. P-hydroxybenzoic acid or its Methylester, 5-bromo-5-nitro-l, 3-dioxane, salicylic, 2-naphthyl-mN-Dimethylthiocarbanilat, 5-chloro -5-methyl-4-isothiazolin-3-one, 2-methyl-4-isothiazolin-3-one, cetyltrimethylammonium chloride (CTAC) and mixtures of these compounds. Another preservative is p-hydroxybenzoic acid or its methyl ester. With the help of these preservatives microbial and fungal infestation of the components can be avoided.
Bei Bedarf können Konfektionierhilfsmittel (Lösungsvermitt¬ ler) zugegeben werden wie bspw. Natriumcumolsulfonat , Nat- riumtoluolsulfonat , Natriumxylolsulfonat , Harnstoff, Glyko- le, insbesondere Polypropylenglykole und Polyethylenglyko- le, Methylacetamid und Fettalkohole, wie bzw. Cetylalkohol . If required, formulation aids can (Lösungsvermitt ¬ ler) are added such as. Sodium cumene sulfonate, NAT riumtoluolsulfonat, sodium xylene sulfonate, urea, glyco- le, in particular polypropylene glycols and Polyethylenglyko- le, methylacetamide and fatty alcohols such as cetyl alcohol or.
Die Aufzählung möglicher Inhaltsstoffe ist nicht abschlie- ßend. Es können zusätzlich bspw. Netzmittel, Emulgatoren, schaumbremsende Mittel oder dergleichen zugesetzt werden. Vorteilhaft ist beispielsweise der Zusatz von N- Acylglutamat als Netzmittel. Ein weiterer Gegenstand der Erfindung ist die Verwendung eines erfindungsgemäßen Kits zur maschinellen Reinigung und/oder Desinfektion medizinischer und/oder chirurgischer Instrumente und/oder Apparate. Eine solche maschinelle Reinigung erfolgt ohne menschliches Zutun während eines automatischen Programmablaufs, insbe¬ sondere in einer üblichen Instrumentenspülmaschine (RDG) . Mit dem Merkmal "Reinigung und/oder Desinfektion" soll zum Ausdruck gebracht werden, dass der erfindungsgemäße Kit so¬ wohl bei der Kombination von Reinigung und Desinfektion in einem einzigen Verfahrensschritt als auch bei Programmab¬ läufen verwendet werden kann, bei denen einem Reinigungsschritt ein separater Desinfektionsschritt nachfolgt. In diesem Fall ist der erfindungsgemäße Kit in beiden dieser Schritte verwendbar. The list of possible ingredients is not exhaustive. In addition, wetting agents, emulsifiers, antifoaming agents or the like may be added, for example. For example, the addition of N-acylglutamate as wetting agent is advantageous. Another object of the invention is the use of a kit according to the invention for the mechanical cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus. Such a machine cleaning takes place without human intervention during an automatic program sequence, in particular ¬ special in a conventional instrument dishwasher (RDG). With the feature "Cleaning and / or disinfection" should be expressed that the kit of the invention ¬ can be used in the combination of cleaning and disinfection in a single step and in Programmab ¬ runs probably the case in which a cleaning step, a separate Disinfection step follows. In this case, the kit according to the invention is usable in both of these steps.
Ebenfalls Gegenstand der Erfindung ist ein Verfahren zum Reinigen von medizinischen und/oder chirurgischen Instrumenten und/oder Apparaten, gekennzeichnet durch folgende Schritte : a) Aufbringen einer 0,05 bis 0,5%igen wässrigen Lösung der Komponenten eines erfindungsgemäßen Kits, b) Einwirkenlassen der Lösung bei einer Temperatur von Raumtemperatur bis zur Siedetemperatur der Lösung, c) Nachspülen. The invention likewise relates to a method for cleaning medical and / or surgical instruments and / or apparatus, characterized by the following steps: a) application of a 0.05 to 0.5% aqueous solution of the components of a kit according to the invention, b) exposure the solution at a temperature from room temperature to the boiling point of the solution, c) rinsing.
Bei dem erfindungsgemäßen Verfahren geschieht das Aufbringen der wässrigen Lösung des Reinigungsmittelkonzentrats vorzugsweise durch Sprühen, kann aber bspw. auch durch Eintauchen oder Begießen erfolgen. Die Prozentangaben sind Gewichtsprozente, sofern im konkreten Einzelfall nicht anders angegeben . Das Einwirkenlassen kann nach dem Aufbringen der Reinigungslösung ein Einwirken in Ruhe, d.h. ohne fortlaufendes Aufbringen bzw. Aufsprühen oder mechanisches Umwälzen bzw. Bewegen der Reinigungslösung umfassen. Bevorzugt ist im Zu- ge des maschinellen Reinigens bzw. Desinfizierens ein stän¬ diges oder unterbrochenes Umwälzen der Reinigungslösung in dem verwendeten RDG, dabei wird die Lösung bevorzugt fort¬ laufend auf die Apparate bzw. Instrumente aufgesprüht bzw. aufgespült . In the method according to the invention, the application of the aqueous solution of the cleaning agent concentrate is preferably carried out by spraying, but may, for example, also take place by immersion or pouring. The percentages are by weight, unless otherwise specified in the specific case. The exposure may after application of the cleaning solution comprise an action at rest, ie without continuous application or spraying or mechanical circulation or moving the cleaning solution. Preferably in the inlet ge of the automatic cleaning and disinfection is a RESISTING ¬ ended or interrupted circulation of the cleaning solution used in the RDG, while the solution is preferably continued ¬ continuously sprayed onto the equipment and instruments, or flushed away.
Die Komponenten des Kits können unmittelbar in die als Reinigungsflotte verwendete wässrige Lösung eindosiert werden. The components of the kit can be metered directly into the aqueous solution used as cleaning liquor.
Das Einwirkenlassen in Schritt b) erfolgt bevorzugt bei Raumtemperatur bis 55°C, vorzugsweise bei 35 bis 50°C, wei¬ ter vorzugsweise bei 40 bis 50°C. The exposure in step b) is preferably carried out at room temperature to 55 ° C, preferably at 35 to 50 ° C, wei ¬ ter preferably at 40 to 50 ° C.
Die wässrige Lösung der Komponenten des Kits weist bevorzugt einen pH-Wert von 9 bis 11, weiter vorzugsweise 10 bis 11 auf. Sofern im Rahmen der vorliegenden Anmeldung pH- Werte einer verdünnten Lösung des Reinigungsmittelkonzent¬ rats gemessen werden, wird als Lösungsmittel vollentsalztes Wasser (VE-Wasser) verwendet. Wenn das Konzentrat mit übli¬ chem Leitungswasser zu einer gebrauchsfertigen Lösung ange- setzt wird, können sich je nach Beschaffenheit dieses Was¬ sers geringfügig abweichende pH-Werte ergeben. The aqueous solution of the components of the kit preferably has a pH of 9 to 11, more preferably 10 to 11. If pH values of a dilute solution of the cleaning agent concentration are measured within the scope of the present application, demineralized water (demineralized water) is used as the solvent. If the concentrate is set with reasonable übli ¬ chem tap water to a use solution, may arise depending on the nature of this What ¬ sers slightly different pH values.
Die Einstellung des pH-Werts der Konzentrate/Komponenten auf den gewünschten Bereich erfolgt ggf. vorzugsweise durch Zusatz von Säuren und/oder geeigneter Puffersysteme. Bevorzugt ist der Zusatz von wenigstens einer organischen Säure ausgewählt aus der Gruppe bestehend aus Mono-, Di- oder Tricarbonsäuren mit 2 bis 6 C-Atomen. Unter diesen Säuren sind bevorzugt Citronensäure, Weinsäure, Apfelsäure, Milch- säure, Glykolsäure, Glyoxylsäure, Bernsteinsäure, Adipin¬ säure und Glutarsäure. Citronensäure ist besonders bevor¬ zugt. Die Säuren werden dem Konzentrat vorzugsweise in ge¬ ringen Mengen zugesetzt. Einige dieser genannten organi- sehen Säuren wie beispielsweise Citronensäure sind gleich¬ zeitig Komplexbildner im Sinne der Erfindung. If desired, the pH of the concentrates / components is adjusted to the desired range by adding acids and / or suitable buffer systems. Preferably, the addition of at least one organic acid is selected from the group consisting of mono-, di- or tricarboxylic acids having 2 to 6 carbon atoms. Among these acids, preference is given to citric acid, tartaric acid, malic acid, acid, glycolic acid, glyoxylic acid, succinic acid, adipic acid and glutaric ¬. Citric acid is especially before ¬ Trains t. The acids are preferably added to the concentrate in small amounts. Some of these mentioned organic acids such as citric acid are equal ¬ time complexing agents according to the invention.
Die Einwirkzeit in Schritt b) beträgt bevorzugt 1 min bis 30 min, weiter vorzugsweise 3 bis 20 min, weiter vorzugs- weise 5 bis 15 min. The exposure time in step b) is preferably 1 minute to 30 minutes, more preferably 3 to 20 minutes, further preferably 5 to 15 minutes.
Im Rahmen des erfindungsgemäßen Verfahrens ist es möglich, das vor Beginn des Reinigungsvorgangs der Typ der medizinischen Instrumente und Apparate durch geeignete technische Maßnahmen erkannt wird und abhängig von diesem Typ ein geeignetes Reinigungs- und Desinfektionsverfahren ausgewählt wird. Die Reinigungs- und Desinfektionsgeräte für das er¬ findungsgemäße Verfahren können erfindungsgemäß eine Pro¬ grammsteuerung zur Durchführung einer Mehrzahl unterschied- licher Reinigungs- und Desinfektionsverfahren aufweisen.Within the scope of the method according to the invention, it is possible to detect the type of medical instruments and apparatus by suitable technical measures before the beginning of the cleaning process and to select a suitable cleaning and disinfection method depending on this type. The cleaning and disinfection equipment for which he ¬ invention modern methods may according to the invention a pro ¬ program control for performing a plurality of different include cleaning and disinfection processes.
Diese Programmsteuerung ist zur bedarfsgerechten Dosierung der beiden Komponenten abhängig von dem durchgeführten Reinigungs- und Desinfektionsverfahren ausgebildet. Die Pro¬ gramme können bevorzugt unterschiedliche Konzentrationen der beiden Komponenten aufweisen und auch das Verhältnis zueinander der verwendeten Komponenten unterschiedlich einstellen. Beispielsweise kann bei der Aufbereitung herkömmlicher chirurgischer Instrumente eine höhere Konzentration der Alkalikomponente gewählt werden als bei der Aufberei- tung empfindlicher Instrumente für die minimalinvasive Chi¬ rurgie (MIC-Instrumente) oder von Endoskopen. Das Volumen¬ verhältnis der beiden Komponenten zueinander kann erfindungsgemäß bevorzugt zwischen 1:10 und 10:1, weiter vor- zugsweise 1:5 und 5:1, weiter vorzugsweise 1:2 und 2:1 lie¬ gen. Bei einer Standardreinigung bzw. -desinfektion kann es beispielsweise 1:1 betragen. Die Konzentration beider Komponenten zusammen in der Reinigungslösung liegt beim erfin- dungsgemäßen Verfahren zwischen 0,05 und 0,5 Gew . ~6 , vor zugsweise 0,08 und 0,3 Gew.-%. Bevorzugte Bereiche für jede einzelne der beiden Komponenten sind 0,02 bis 0,3 Gew.-%, weiter vorzugsweise 0,04 und 0,15 Gew.-%. Die unterschiedlichen Programme und die dabei jeweils ein¬ gesetzten Komponenten sowie deren Konzentrationen und Konzentrationsverhältnisse können als zugelassene Prozesse zur Aufbereitung von Medizinprodukten validiert werden. Es ist dann eine einfache und vollständige Dokumentation aller Aufbereitungsvorgänge einschließlich Art, Menge und gegebe¬ nenfalls auch Chargennummer der verwendeten Komponenten möglich . This program control is designed to demand-based dosing of the two components depending on the performed cleaning and disinfection process. The Pro ¬ programs may preferably have different concentrations of the two components and also adjust the ratio to each other of the components used in different ways. For example, in the preparation of conventional surgical instruments, a higher concentration of the alkali component can be chosen as in the treatment of sensitive instruments for minimally invasive Chi ¬ rurgie (MIS instruments) or endoscopes. The volume ratio of the two components to each other ¬ can according to the invention preferably is between 1:10 and 10: 1, more pre- preferably 1: 5 and 5: 1, more preferably 1: 2 and 2:. 1 lie ¬ gene in a standard cleaning or disinfection, it may for example be 1: 1. The concentration of both components together in the cleaning solution in the inventive method is between 0.05 and 0.5 wt. ~ 6, preferably 0.08 and 0.3 wt .-% before. Preferred ranges for each of the two components are 0.02 to 0.3 wt%, more preferably 0.04 and 0.15 wt%. The different programs and eliminating any ¬ set components and their concentrations and concentration ratios can be validated as approved processes for reprocessing of medical devices. It is then a simple and complete documentation of all processing operations, including the type, quantity and, where applicable, ¬ and batch number of the components used possible.
Erfindungsgemäß kann vorgesehen sein, dass eine Einrichtung zur Erkennung des Typs der zu reinigenden und desinfizierenden medizinischen Instrumente und Apparate und zur Aus¬ wahl eines geeigneten Reinigungs- und Desinfektionsverfahrens bzw. -Programms abhängig von diesem Typ vorgesehen ist. Diese Vorgehensweise kann insbesondere dann sinnvoll sein, wenn jeweils Chargen identischer oder ähnlicher Instrumente gereinigt werden, beispielsweise übliche chirur¬ gische Instrumente, MIC-Instrumente oder dergleichen. Die Erkennung des Typs der Instrumente kann mechanisch oder optisch erfolgen, beispielsweise durch Abtasten der Höhe im Instrumentenkorb, optische Erkennung der Instrumente oder dergleichen. Bevorzugt ist es, wenn entweder an den Instrumenten selbst oder an den Körben, mittels denen diese in das Reinigungs- und Desinfektionsgerät verbracht werden, Codiereinrichtungen vorhanden sind, die mit entsprechenden Leseeinrichtungen des Reinigungs- und Desinfektionsgerätes zusammenwirken. Beispielsweise kann es sich hierbei um RFID-Tags und RFID-Leseeinrichtungen handeln. According to the invention it can be provided that a device for recognition of the type which is intended to cleaning and disinfecting medical instruments and equipment and to the off ¬ choice of a suitable cleaning and disinfecting method and -Programms function of this type. This approach may be particularly useful if each batch of identical or similar instruments are cleaned, for example, conventional chirur ¬ gical instruments, MIC instruments or the like. The detection of the type of instruments can be mechanical or optical, for example by scanning the height in the instrument basket, optical detection of the instruments or the like. It is preferred if either on the instruments themselves or on the baskets, by means of which they are brought into the washer-disinfector, Coding devices are present, which interact with corresponding reading devices of the washer-disinfector. For example, these may be RFID tags and RFID readers.
Bei dem erfindungsgemäßen Verfahren kann der Typ der In the method according to the invention, the type of
Instrumente und Apparate ausgewählt sein aus der Gruppe bestehend aus konventionellen chirurgischen Instrumenten, Instrumenten für die minimalinvasive Chirurgie, Endoskopen und deren Teilen, Instrumenten für die Neurochirurgie,Instruments and apparatus selected from the group consisting of conventional surgical instruments, instruments for minimally invasive surgery, endoscopes and their parts, instruments for neurosurgery,
Instrumenten für die Augenchirurgie, Anästhesie-Utensilien, Container für medizinischen Instrumente und Apparate, und OP-Schuhen . Die Erfindung wird nachfolgend anhand von Ausführungsbei¬ spielen erläutert. Instruments for ophthalmic surgery, anesthetic utensils, containers for medical instruments and apparatus, and surgical shoes. The invention will be explained below with reference to Ausführungsbei ¬ play.
Beispiel 1 Eine erfindungsgemäße Alkalikomponente wird anhand der An¬ gaben der nachfolgenden Tabelle zubereitet. Die Mengen der einzusetzenden Ausgangsstoffe sind in Gewichtsteilen angegeben . Example 1 An alkali component according to the invention is prepared on the basis of the data given in the following table. The amounts of the starting materials to be used are given in parts by weight.
Triethanolamin 99% 20,0Triethanolamine 99% 20.0
MDGB1 2,0MDGB 1 2.0
KOH, 45% 3,0KOH, 45% 3.0
MGDA 3 Na, 40% 40,0MGDA 3 Na, 40% 40.0
Acumer® 20002 3' 5 Acumer® 2000 2 3 ' 5
Wasser (vollentsalzt) 31,5 pH-Wert des Konzentrats 11,8 pH-Wert einer 0,l%igen wässrigen Lösung 10,8 (in VE-Wasser) Water (deionized) 31.5 pH of the concentrate 11.8 pH of a 0.1% aqueous solution 10.8 (in dem. Water)
Eine erfindungsgemäße Enzymkomponente wird wie folgt herge- stellt: An enzyme component according to the invention is prepared as follows:
Na-Cumolsulfonat 40% 5,0Na cumene sulphonate 40% 5.0
Subtilisin 10,0Subtilisin 10.0
FA C12/C14; 2EO/4P03 0,8FA C12 / C14; 2EO / 4P0 3 0.8
FA C12/C14; 5EO/4PO 3,0FA C12 / C14; 5EO / 4PO 3.0
FA C12/C15; 2EO/6PO 0,1FA C12 / C15; 2EO / 6PO 0.1
CTAC 0,2CTAC 0.2
Mischung Zitr . /Apfelsäure 40% 0,28Mix citr. / Malic acid 40% 0.28
KOH, 45% 0,02KOH, 45% 0.02
Wasser (vollentsalzt) 80,6 pH-Wert des Konzentrats 11,8 pH-Wert einer 0,l%igen wässrigen Lösung 10,8 (in VE-Wasser) Water (deionized) 80.6 pH of the concentrate 11.8 pH of a 0.1% aqueous solution 10.8 (in dem. Water)
1 Diester der Phosphorsäure mit Butanol und Ethylenglykol 1 Diester of phosphoric acid with butanol and ethylene glycol
2 Komplexbildner auf Basis von Carboxylat/Sulfonat-Acrylcopolymeren, Fa. Rohm and Haas 2 complexing agents based on carboxylate / sulfonate-acrylic copolymers, Rohm and Haas
3 Ethoxylierte/propoxylierte Fettalkohole Beispiel 2 3 ethoxylated / propoxylated fatty alcohols Example 2
In diesem Beispiel wird die Reinigungsleistung der Erfindung geprüft. In this example, the cleaning performance of the invention is tested.
Als Substrat für eine Testanschmutzung dienten raue DIN- Metallplättchen mit einer Größe von 1 x 9 cm. As a substrate for a test staining used rough DIN metal flakes with a size of 1 x 9 cm.
10 ml heparinisiertes Hammelblut (Fa. Acila) werden mit 1 ml VE-Wasser gemischt und mit 150 μΐ Protaminsulfat (1.000 I.E. /ml zur Inaktivierung von jeweils 1.000 I.E. Heparin) wieder gerinnungsfähig gemacht. Das so vorbereitete Blut wurde auf die Metallplättchen aufgetragen und über Nacht bei Raumtemperatur getrocknet. 10 ml of heparinized mutton blood (Acila) are mixed with 1 ml of deionised water and re-coagulated with 150 μl protamine sulfate (1,000 IU / ml to inactivate 1,000 IU heparin each). The thus prepared blood was applied to the metal flakes and dried overnight at room temperature.
In ein 1000 ml Becherglas wurden 900 ml Reinigungslösung gegeben. Diese Reinigungslösung enthielt erfindungsgemäß jeweils 0,1 Vol.-% der beiden Komponenten des Beispiels 1. In einem zweiten Becherglas enthielt die Reinigungslösung als Vergleichsbeispiel 1 Vol.-% des Konzentrats des Bei¬ spiels 1 der EP 1 327 674 AI (Vergleichsbeispiel) . In a 1000 ml beaker, 900 ml of cleaning solution were added. This cleaning solution contained in the present invention respectively 0.1 vol .-% of the two components of Example 1. In a second beaker, the cleaning solution contained, as Comparative Example 1 vol .-% of the concentrate of the case ¬ game 1 of EP 1327674 Al (comparative example).
Die Reinigungslösungen wurden auf 55 °C erwärmt und mit ei¬ nem Magnetrührer bei Stufe 3,5 gerührt. Die Metallplättchen wurden für 5 min in die Lösungen eingetaucht und danach mit VE-Wasser abgespült. Anschließend wurden die Metallplätt¬ chen über Nacht getrocknet, visuell beurteilt, danach mit 0,1 %iger Amidoschwarzlösung zur Prüfung auf verbleibende Restmengen von Proteinen eingefärbt und erneut visuell be- urteilt. The cleaning solutions were heated to 55 ° C and stirred with egg ¬ nem magnetic stirrer at 3.5. The metal flakes were immersed in the solutions for 5 minutes and then rinsed with deionised water. Subsequently, the Metallplätt ¬ surfaces were dried overnight, evaluated visually, then stained with 0.1% Amidoschwarzlösung for testing for residual amounts of proteins and re-evaluated visually.
Die erzielte Reinigungsleistung gemäß dem Beispiel der Erfindung war identisch wie die Reinigungsleistung des Ver- gleichsbeispiels . Dieses Beispiel belegt somit, dass sich mit wesentlich geringeren Konzentrationen von Reinigungsmitteln als im als Vergleichsbeispiel herangezogenen Stand der Technik und damit auch mit lediglich einem Bruchteil der eingesetzten Volumina von Reinigungskomponenten eine ebenso gute Reinigungsleistung erzielen lässt. Dies ist überraschend und aus dem Stand der Technik nicht ableitbar. The achieved cleaning performance according to the example of the invention was identical to the cleaning performance of the same example. This example thus proves that an equally good cleaning performance can be achieved with substantially lower concentrations of cleaning agents than in the prior art used as comparative example and thus also with only a fraction of the volumes of cleaning components used. This is surprising and not derivable from the prior art.
Beispiel 3 Example 3
Beim Reinigen bzw. Desinfizieren in einem RDG soll die Reinigungslösung möglichst effektiv umgepumpt werden. Behindert werden kann dieses Umpumpen durch unerwünschtes Schäu¬ men der eingesetzten Tenside, dies führt dazu, dass der Pumpendruck sinkt und das Umwälzen beeinträchtigt wird. When cleaning or disinfecting in a RDG, the cleaning solution should be pumped as effectively as possible. May be hampered by this pumping unwanted Schäu ¬ men of the surfactants used, this results in that the pump pressure decreases and the circulation is impaired.
Da die Komponenten des erfindungsgemäßen Kits in deutlich geringeren Konzentrationen eingesetzt werden als Reinigungsmittel des Standes der Technik, steht zu erwarten, dass dieses unerwünschte Schäumen in geringerem Maße als im Stand der Technik auftritt. Since the components of the kit according to the invention are used in significantly lower concentrations than detergents of the prior art, it is to be expected that this undesired foaming will occur to a lesser extent than in the prior art.
Um dies zu prüfen, wurde in einem RDG Miele PG 8536 der Um¬ wälzpumpendruck gemessen beim Umwälzen der Reinigungslösung im Niedertemperaturbereich bei 30 °C. In diesem Temperaturbereich, der beim Aufheizen der Flotte durchlaufen wird, ist die Lösung besonders empfindlich gegenüber Schäumen. To check this, was dissolved in a RDG Miele PG 8536 to the ¬ wälzpumpendruck measured during circulation of the cleaning solution in the low temperature range at 30 ° C. In this temperature range, which is passed through the heating of the fleet, the solution is particularly sensitive to foaming.
Es zeigte sich, dass eine Lösung, die jeweils 0,1 Vol.-% der beiden Komponenten eines erfindungsgemäßen Kits enthält, einen nur sehr geringfügigen Abfall des Pumpendrucks zeigt, während eine Lösung gemäß dem Stand der Technik (1 Vol.-% des Beispiels 1 der EP 1 327 674 AI) einen deutli¬ cheren Abfall des Pumpendrucks zeigte. It was found that a solution containing in each case 0.1% by volume of the two components of a kit according to the invention shows only a very slight drop in the pump pressure, whereas a solution according to the prior art (1 Vol .-% of Example 1 of EP 1327674 Al) showed a MACHINES SHOW ¬ Cheren drop in pump pressure.

Claims

Patentansprüche claims
Kit zur maschinellen Reinigung und/oder Desinfektion medizinischer und/oder chirurgischer Instrumente und/oder Apparate, dadurch gekennzeichnet, dass er enthält : eine erste Komponente, die wenigstens 15 Gew.-% Alkanolamin und wenigstens 10 Gew.-% Komplexbild ner enthält; eine zweite Komponente, die wenigstens ein Enzym enthält . A kit for the automated cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus, characterized in that it contains: a first component containing at least 15% by weight alkanolamine and at least 10% by weight complexing agent; a second component containing at least one enzyme.
Kit nach Anspruch 1, dadurch gekennzeichnet, dass der Alkanolamingehalt 15 bis 30 Gew.-%, vorzugsweise 15 bis 25 Gew.-% beträgt. Kit according to claim 1, characterized in that the alkanolamine content is 15 to 30 wt .-%, preferably 15 to 25 wt .-%.
Kit nach einem der Ansprüche 1 bis 2, dadurch gekenn zeichnet, dass das Alkanolamin folgende Struktur auf weist : Kit according to one of claims 1 to 2, characterized in that the alkanolamine has the following structure:
R2 R2
R! - N - R3 wobei R]_ eine Hydroxyalkylgruppe mit 1 bis 6 C-Atomen darstellt und wobei R2 und R3 unabhängig voneinander die genannte Hydroxyalkylgruppe oder Wasserstoff dar¬ stellen . R! - R 3 wherein R] _ is a hydroxyalkyl group having 1 to 6 carbon atoms and wherein R2 and R3 represent independently of one another the said hydroxyalkyl group or hydrogen ¬ - N.
Kit nach Anspruch 3, dadurch gekennzeichnet, dass das Alkonolamin Mono-, Di- und/oder Triethanolamin um- fasst Kit according to claim 3, characterized in that the alkonolamine mono-, di- and / or triethanolamine um- summarizes
Kit nach einem der Ansprüche 1 bis 4, dadurch gekenn zeichnet, dass die erste Komponente 10 bis 30 Gew.-% vorzugsweise 15 bis 25 Gew.-% Komplexbildner enthält Kit according to one of claims 1 to 4, characterized in that the first component contains 10 to 30 wt .-%, preferably 15 to 25 wt .-% complexing agent
Kit nach einem der Ansprüche 1 bis 5, dadurch gekenn zeichnet, dass er als Komplexbildner Chelatbildner, vorzugsweise Chelatbildner ausgewählt aus der Gruppe bestehend aus Aminopolycarbonsäuren und deren Salzen enthält . Kit according to one of claims 1 to 5, characterized in that it contains as complexing agents chelating agents, preferably chelating agents selected from the group consisting of aminopolycarboxylic acids and their salts.
Kit nach einem der Ansprüche 1 bis 6, dadurch gekenn zeichnet, dass die zweite Komponente wenigstens ein proteolytisches Enzym enthält. Kit according to one of claims 1 to 6, characterized in that the second component contains at least one proteolytic enzyme.
Kit nach einem der Ansprüche 1 bis 7, dadurch gekennzeichnet, dass die zweite Komponente Tenside, vorzugs¬ weise nichtionische Tenside, enthält. Kit according to one of claims 1 to 7, characterized in that the second component surfactants, preferably nonionic surfactants containing ¬ example.
Verwendung eines Kits nach einem der Ansprüche 1 bis ί zur maschinellen Reinigung und/oder Desinfektion medizinischer und/oder chirurgischer Instrumente und/oder Apparate . Use of a kit according to one of claims 1 to 6 for the mechanical cleaning and / or disinfection of medical and / or surgical instruments and / or apparatus.
Verfahren zum Reinigen von medizinischen und/oder chirurgischen Instrumenten und/oder Apparaten, gekennzeichnet durch folgende Schritte: a) Aufbringen einer 0,05 bis 0,5%igen wässrigen Lösung der Komponenten eines Kits nach einem der Ansprüche 1 bis 8, Einwirkenlassen der Lösung bei einer Temperatur von Raumtemperatur bis zur Siedetemperatur der Lösung, c) Nachspülen. Method for cleaning medical and / or surgical instruments and / or apparatus, characterized by the following steps: a) application of a 0.05 to 0.5% aqueous solution of the components of a kit according to one of claims 1 to 8, Allowing the solution to react at a temperature from room temperature to the boiling point of the solution, c) rinsing.
11. Verfahren nach Anspruch 10, dadurch gekennzeichnet, dass das Einwirkenlassen in Schritt b) bei Raumtempe¬ ratur bis 55°C, vorzugsweise bei 35 bis 50°C, weiter vorzugsweise bei 40 bis 50°C, geschieht. 11. The method according to claim 10, characterized in that the exposure in step b) at room Tempe ¬ temperature to 55 ° C, preferably at 35 to 50 ° C, more preferably at 40 to 50 ° C, occurs.
12. Verfahren nach Anspruch 10 oder 11, dadurch gekennzeichnet, dass die wässrige Lösung der Komponenten des Kits einen pH-Wert von 9 bis 11, vorzugsweise 10 bis 11 aufweist. 12. The method according to claim 10 or 11, characterized in that the aqueous solution of the components of the kit has a pH of 9 to 11, preferably 10 to 11.
13. Verfahren nach einem der Ansprüche 10 bis 12, dadurch gekennzeichnet, dass die Einwirkzeit in Schritt b) 1 min bis 30 min, weiter vorzugsweise 3 bis 20 min, wei¬ ter vorzugsweise 5 s bis 15 min beträgt 13. The method according to any one of claims 10 to 12, characterized in that the reaction time in step b) 1 min to 30 min, more preferably 3 to 20 min, wei ¬ ter preferably 5 s to 15 min
14. Verfahren nach einem der Ansprüche 10 bis 13, dadurch gekennzeichnet, dass es zusätzlich die Schritte des Erkennens des Typs der medizinischen Instrumente und Apparate und der Auswahl eines geeigneten Reinigungs- und Desinfektionsverfahrens abhängig von diesem Typ umfasst . A method according to any one of claims 10 to 13, characterized in that it additionally comprises the steps of recognizing the type of medical instruments and apparatus and selecting a suitable cleaning and disinfecting method depending on this type.
15. Verfahren nach Anspruch 14, dadurch gekennzeichnet, dass der Typ der Instrumente und Apparate ausgewählt ist aus der Gruppe bestehend aus konventionellen chirurgischen Instrumenten, Instrumenten für die minimalinvasive Chirurgie, Endoskopen und deren 15. The method according to claim 14, characterized in that the type of instruments and apparatus is selected from the group consisting of conventional surgical instruments, instruments for minimally invasive surgery, endoscopes and their
Teilen, Instrumenten für die Neurochirurgie, Instrumenten für die Augenchirurgie, Anästhesie- Utensilien, Container für medizinischen Instrumente und Apparate, und OP-Schuhe. Parts, instruments for neurosurgery, Instruments for ophthalmic surgery, anesthetic utensils, containers for medical instruments and apparatus, and surgical shoes.
EP14727524.2A 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses Active EP3063327B1 (en)

Priority Applications (6)

Application Number Priority Date Filing Date Title
SI201431089T SI3063327T1 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses
PL14727524T PL3063327T3 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses
EP14727524.2A EP3063327B1 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses
RS20190181A RS58348B1 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses
CY20191100210T CY1121271T1 (en) 2013-09-26 2019-02-15 W <KIT AND METHOD FOR CLEANING AND DISINFECTING MEDICAL TOOLS AND MACHINERY
HRP20190316TT HRP20190316T1 (en) 2013-09-26 2019-02-18 Kit and method for cleaning and disinfecting medical instruments and apparatuses

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13186209.6A EP2853632A1 (en) 2013-09-26 2013-09-26 Kit and method for cleaning and disinfecting medical instruments and apparatuses
EP14727524.2A EP3063327B1 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and apparatuses
PCT/EP2014/061352 WO2015043777A1 (en) 2013-09-26 2014-06-02 Kit and method for cleaning and disinfecting medical instruments and appliances

Publications (2)

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EP3063327A1 true EP3063327A1 (en) 2016-09-07
EP3063327B1 EP3063327B1 (en) 2018-12-05

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EP (2) EP2853632A1 (en)
JP (1) JP2016535110A (en)
CN (1) CN105992845B (en)
AU (1) AU2014327731B2 (en)
CY (1) CY1121271T1 (en)
DK (1) DK3063327T3 (en)
ES (1) ES2711366T3 (en)
HR (1) HRP20190316T1 (en)
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CN112625816B (en) * 2020-12-29 2021-09-24 武汉瑞法医疗器械有限公司 Method for cleaning disinfectant containing guanidine compound on surface of medical equipment

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PL3063327T3 (en) 2019-05-31
US10364407B2 (en) 2019-07-30
ES2711366T3 (en) 2019-05-03
HRP20190316T1 (en) 2019-04-19
SA516370821B1 (en) 2022-02-13
EP3063327B1 (en) 2018-12-05
TR201901942T4 (en) 2019-03-21
RU2662133C2 (en) 2018-07-23
LT3063327T (en) 2019-06-25
RU2016115786A (en) 2017-10-26
SI3063327T1 (en) 2019-03-29
PT3063327T (en) 2019-02-19
RS58348B1 (en) 2019-03-29
AU2014327731B2 (en) 2018-09-20
CN105992845A (en) 2016-10-05
CY1121271T1 (en) 2020-05-29
NZ719416A (en) 2021-05-28
JP2016535110A (en) 2016-11-10
CN105992845B (en) 2019-06-25
HUE041389T2 (en) 2019-05-28
AU2014327731A1 (en) 2016-05-19
DK3063327T3 (en) 2019-02-25
MY176564A (en) 2020-08-17
US20160230126A1 (en) 2016-08-11
EP2853632A1 (en) 2015-04-01

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